FDA Medical Device Recalls (openFDA)
Busse Hospital Disposables, Inc.: Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
- Recall number
- Z-0592-2024
- Recalling firm
- Busse Hospital Disposables, Inc.
- Product
- Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
- Status
- Open, Classified
- Initiated
- 2023-11-30
- Posted
- 2024-01-03
- Terminated
- not on file
- Reason
- Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
- Root cause
- Nonconforming Material/Component
- Action
- On November 21, 2023, the firm notified affected distributors via URGENT MEDICAL DEVICE RECALL letters. Customers were asked to segregate and destroy any affected kits. Distributors should also inform their customers of the recall. Customers should return any affected product to their distributor. For questions, email NurseAssistRecall@busseinc.com
- Quantity
- 705
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI 00849233010000 Lots 2210099 2210135 2210337 2210377 2310181 2310233 2310291
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NXA
- Firm FEI
- 2433012
- Firm city
- Hauppauge
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28